Implantable electrodes with remote power delivery for treating sleep apnea, and associated systems and methods

ABSTRACT

Implantable electrodes with power delivery wearable for treating sleep apnea, and associated systems and methods are disclosed herein. A representative system includes non-implantable signal generator worn by the patient and having an antenna that directs a mid-field RF power signal to an implanted electrode. The implanted electrode in turn directs a lower frequency signal to a neural target, for example, the patient&#39;s hypoglossal nerve. Representative signal generators can have the form of a mouthpiece, a collar or other wearable, and/or a skin-mounted patch.

CROSS REFERENCE TO RELATED APPLICATION

The present application claims priority to U.S. Provisional App. No.63/109,809, filed Nov. 4, 2020 and incorporated herein by reference. Tothe extent the foregoing application and/or any other materials conflictwith the present disclosure, the present disclosure controls.

TECHNICAL FIELD

The present technology is directed generally to implantable electrodeswirelessly coupled to a remote power delivery device for treating sleepapnea, and associated systems and methods. Representative power deliverydevices include a mouthpiece, a device worn in a collar or other neckclothing forms, and/or an adhesive skin-mounted device.

BACKGROUND

Obstructive sleep apnea (OSA) is a medical condition in which apatient's upper airway is occluded (partially or fully) during sleep,causing sleep arousal. Repeated occlusions of the upper airway may causesleep fragmentation, which in turn may result in sleep deprivation,daytime tiredness, and/or malaise. More serious instances of OSA mayincrease the patient's risk for stroke, cardiac arrhythmias, high bloodpressure, and/or other disorders.

OSA may be characterized by the tendency for soft tissues of the upperairway to collapse during sleep, thereby occluding the upper airway. OSAis typically caused by the collapse of the patient's soft palate,oropharynx, tongue, epiglottis, or combination thereof, into the upperairway, which in turn may obstruct normal breathing and/or cause arousalfrom sleep.

Some treatments have been available for OSA including, for example,surgery, constant positive airway pressure (CPAP) machines, andelectrically stimulating muscles or related nerves associated with theupper airway to move the tongue (or other upper airway tissue). Surgicaltechniques have included tracheotomies, procedures to remove portions ofa patient's tongue and/or soft palate, and other procedures that seek toprevent the tongue from collapsing into the back of the pharynx. Thesesurgical techniques are very invasive. CPAP machines seek to maintainupper airway patency by applying positive air pressure at the patient'snose and mouth. However, these machines are uncomfortable, cumbersome,and may have low compliance rates.

Some electrical stimulation techniques seek to prevent the tongue fromcollapsing into the back of the pharynx by causing the tongue toprotrude forward (e.g., in an anterior direction) and/or flatten duringsleep. However, existing techniques for electrically stimulating thenerves of the patient's oral cavity suffer from being too invasive,and/or not sufficiently efficacious. Thus, there is a need for animproved minimally-invasive treatment for OSA and other sleep disorders.

BRIEF DESCRIPTION OF THE DRAWINGS

Representative embodiments of the present technology are illustrated byway of example and are not intended to be limited by the Figures, inwhich like reference numerals generally refer to corresponding partsthroughout.

FIG. 1 is a side sectional view depicting a patient's upper airway.

FIG. 2A is a view of a patient's skull, from below, illustrating thehypoglossal nerve and a representative electrode location in accordancewith embodiments of the present technology.

FIG. 2B is a side view of a patient's skull, illustrating furtherrepresentative signal delivery targets in accordance with embodiments ofthe present technology.

FIG. 3A is a block diagram illustrating elements of a system fortreating sleeping disorders in accordance with embodiments of thepresent technology.

FIG. 3B is a partially schematic, side sectional view of a patient'supper airway, and elements of a system for treating sleeping disordersin accordance with embodiments of the present technology.

FIG. 4 is a partially schematic illustration of a signal delivery deviceconfigured in accordance with embodiments of the present technology.

FIG. 5A is a partially schematic illustration of a signal generatorhaving an upper mouthpiece portion, a lower mouthpiece portion, and acircuit and power supply positioned at an inner surface of the lowermouthpiece portion.

FIG. 5B is a partially schematic illustration of a signal generatorhaving an upper mouthpiece portion, a lower mouthpiece portion, and acircuit and power supply positioned at an inner surface of the uppermouthpiece portion.

FIG. 5C is a partially schematic illustration of a signal generatorhaving an upper mouthpiece portion, a lower mouthpiece portion, and acircuit and power supply positioned at an outer surface of the upperand/or lower mouthpiece portions.

FIG. 6 is a partially schematic, isometric illustration of a signaldelivery device having an upper mouthpiece portion with a roof portioncarrying circuitry, a power supply, one or more sensors, and/or a datatransceiver antenna, in accordance with representative embodiments ofthe present technology.

FIG. 7 is a partially schematic illustration of multiple arrangementsfor controlling individual electrodes with control circuitry, inaccordance with embodiments of the present technology.

FIG. 8A is a representative example of a waveform having waveformparameters selected in accordance with embodiments of the presenttechnology.

FIG. 8B is a representative example of a waveform having active andresting periods in accordance with embodiments of the presenttechnology.

DETAILED DESCRIPTION

The present technology is discussed under the following headings forease of readability:

-   -   Heading 1: “Introduction”    -   Heading 2: “Representative Stimulation Targets” (with a focus on        FIGS. 1-2B)    -   Heading 3: “Representative Devices and Methods” (with a focus on        FIGS. 3A-7)    -   Heading 4: “Representative Waveforms” (with a focus on FIGS. 8A        and 8B)

While embodiments of the present technology are described under theselected headings indicated above, other embodiments of the technologycan include elements discussed under multiple headings. Accordingly, thefact that an embodiment may be discussed under a particular heading doesnot necessarily limit that embodiment to only the elements discussedunder that heading.

1. Introduction

Electrical stimulation for obstructive sleep apnea (OSA) typicallyincludes delivering an electrical current that modulates nerves and/ormuscles, e.g., to cause the tongue and/or other soft tissue to move. Theelectrical stimulation can accordingly remove an obstruction of theupper airway, or prevent the tongue or other soft tissue from collapsingor obstructing the airway. As used herein, the terms “modulate” and“stimulate” are used interchangeably to mean having an effect on, e.g.,an effect on a nerve that in turn has an effect on one or more motorfunctions, e.g., a breathing-related motor function.

Representative methods and apparatuses for reducing the occurrenceand/or severity of a breathing disorder, such as OSA, are disclosedherein. In accordance with representative embodiments, aminimally-invasive signal delivery device is implanted proximate to oradjacent to nerves that innervate the patient's oral cavity, softpalate, oropharynx, and/or epiglottis. Representative nerves include thehypoglossal nerve, branches of the ansa cervicalis and/or the vagusnerves, which are located adjacent and/or around the oral cavity or inthe neck. The signal delivery device can be implanted in the patient viaa percutaneous injection. A non-implanted power source, e.g., includingone or more mouthpiece portions, collar portions, chinstrap portions,pillow portions, mattress overlay portions, other suitable “wearables,”and/or one or more adhesive, skin-mounted devices, can wirelesslyprovide electrical power to the implanted signal delivery device. Thesignal delivery device emits accurately targeted electrical signals(e.g., pulses) that improve the patient's upper airway patency and/orimprove the tone of the tissue of the intraoral cavity to treat sleepapnea. The electrical current delivered by the signal delivery devicecan stimulate efferent, peripheral nerves, e.g., at least a portion of apatient's hypoglossal nerve and/or other nerves associated with theupper airway. By moving the tongue forward and/or by preventing thetongue and/or soft tissue from collapsing onto the back of the patient'spharynx, and/or into the upper airway, the devices and associatedmethods disclosed herein can in turn improve the patient's sleep, e.g.,by moving the potentially obstructing tissue in the upper airway/pharynxdown. More specifically, applying the electrical signal to the medialbranch of the hypoglossal nerve can cause the tongue to move forward(anteriorly), and applying the electrical signal to the ansa cervicaliscan cause the thyroid, larynx, trachea, and/or any of the tissues (e.g.,cartilage) thereof, to move downward (inferiorly or caudally), a motiontypically referred to as caudal traction. The system can also includeone or more feedback and/or diagnostic devices or features that controlthe presence, timing, and/or manner in which the electrical therapy isprovided to the patient. Accordingly, one or more sensors can detectpatient characteristics (e.g., sleep state, wake state, and/orrespiratory characteristics), which then can be used to meter thetherapy, in real-time, or near real-time. As a result, the system candeliver the therapy to the neural target only when the patient isasleep, and/or only when the patient's respiratory performance (e.g.,oxygen perfusion level) indicates that the therapy is necessary orhelpful.

Many embodiments of the technology described below may take the form ofcomputer- or machine- or controller-executable instructions, includingroutines executed by a programmable computer or controller. Thoseskilled in the relevant art will appreciate that the technology can bepracticed on computer/controller systems other than those shown anddescribed below. The technology can be embodied in a special-purposecomputer, controller or data processor that is specifically programmed,configured or constructed to perform one or more of thecomputer-executable instructions described below. Accordingly, the terms“computer” and “controller” as generally used herein refer to anysuitable data processor and can include Internet appliances andhand-held devices (including palm-top computers, wearable computers,tablets, cellular or mobile phones, multi-processor systems,processor-based or programmable consumer electronics, network computers,mini computers and the like). Information handled by these computers canbe presented at any suitable display medium, including a liquid crystaldisplay (LCD).

The present technology can also be practiced in distributedenvironments, where tasks or modules are performed by remote processingdevices that are linked through a communications network. In adistributed computing environment, program modules or subroutines may belocated in local and remote memory storage devices. Aspects of thetechnology described below may be stored or distributed on any suitablecomputer-readable media, including one or more ASICs, (e.g., withaddressable memory), as well as distributed electronically overnetworks. Data structures and transmissions of data particular toaspects of the technology are also encompassed within the scope of theembodiments of the technology.

2. Representative Stimulation Targets

Representative embodiments described herein include signal deliverydevices having electrodes that can be positioned to deliver one or moreelectrical currents to one or more specific target locations, e.g.,specific nerves and/or specific positions along a nerve. FIG. 1illustrates the general anatomy of the patient's oral cavity, and laterFigures illustrate specific target locations. Such locations includelocations along the patient's hypoglossal nerve, branches of the ansacervicalis, and/or vagus nerves, as those nerves innervate muscles ofairway (e.g., palatal, oropharyngeal, laryngeal muscles) besides thetongue. The target location can be identified with respect to any of, orany combination of, intrinsic or extrinsic muscles, associated nervebranches, and/or other physiological features. Such a target locationand/or position can also be distal from the salivary glands (e.g.,medial to the sublingual salivary gland) and/or other structures toavoid causing pain and/or other undesired effects.

FIG. 1 illustrates a patient P relative to a coordinate system in whichthe x-axis denotes the anterior-posterior directions, the y-axis denotesthe superior-inferior directions, and the z-axis denotes themedial-lateral directions. The patient P has a hard palate HP whichoverlies the tongue T and forms the roof of the oral cavity OC (e.g.,the mouth). The hard palate HP includes bone support BS, and thus doesnot typically deform during breathing. The soft palate SP, which is madeof soft tissue such as membranes, fibrous material, fatty tissue, andmuscle tissue, extends rearward (e.g., in a posterior direction) fromthe hard palate HP toward the back of the pharynx PHR. Morespecifically, an anterior end AE of the soft palate SP is anchored to aposterior end of the hard palate HP, and a posterior end PE of the softpalate SP is unattached. Because the soft palate SP does not containbone or hard cartilage, the soft palate SP is flexible and may collapseonto the back of the pharynx PHR and/or flap back and forth (e.g.,especially during sleep).

The pharynx PHR, which passes air from the oral cavity OC and the nasalcavity NC into the trachea TR, is the part of the throat situatedinferior to (below) the nasal cavity NC, posterior to (behind) the oralcavity OC, and superior to (above) the esophagus ES. The pharynx PHR isseparated from the oral cavity OC by the palatoglossal arch PGA, whichruns downward on either side to the base of the tongue T. Although notshown for simplicity, the pharynx PHR includes the nasopharynx, theoropharynx, and the laryngopharynx. The nasopharynx lies between anupper surface of the soft palate SP and the wall of the throat (i.e.,superior to the oral cavity OC). The oropharynx lies behind the oralcavity OC, and extends from the uvula U to the level of the hyoid boneHB. The oropharynx opens anteriorly into the oral cavity OC. The lateralwall of the oropharynx includes the palatine tonsil, and lies betweenthe palatoglossal arch PGA and the palatopharyngeal arch. The anteriorwall of the oropharynx includes the base of the tongue T and theepiglottic vallecula. The superior wall of the oropharynx includes theinferior surface of the soft palate SP and the uvula U. Because bothfood and air pass through the pharynx PHR, a flap of connective tissuecalled the epiglottis EP closes over the glottis (not shown forsimplicity) when food is swallowed to prevent aspiration. Thelaryngopharynx is the part of the throat that connects to the esophagusES, and lies inferior to the epiglottis EP. Below the tongue T is thelower jaw or mandible M, and the geniohyoid muscle GH, which is one ofthe muscles that controls the movement of the tongue T.

FIG. 2A is a partially schematic, isometric illustration of thepatient's skull, looking upwardly toward the mandible M. FIG. 2A alsoillustrates the hypoglossal nerve HGN which innervates the musclescontrolling the patient's tongue T (FIG. 1). In representativeembodiments, one or more electrodes 131 are positioned along thehypoglossal nerve HGN, in particular, at the medial branch of the HGN,in an electrode plane 132 defined by the medial branch. By preciselypositioning the electrode(s) 131 within this plane 132, and adjacent tothe hypoglossal nerve HGN, it is expected that systems in accordancewith embodiments of the present technology can more effectively controlthe patient's airway patency, without causing discomfort, and/or otherundesirable effects, and/or in a manner that reduces the amount of powerrequired to produce effective therapy signals. As discussed elsewhereherein, other representative target nerves include the ansa cervicalisand vagal nerves. Still further representative targets include cranialnerves (e.g., the glossopharangeal nerve), and the palatoglossus muscle.FIG. 2B illustrates these targets. Representative systems for producingthe foregoing and/or other outcomes via signals directed to the abovetargets are described further below with reference to FIGS. 3-8B.

3. Representative Devices and Methods

FIG. 3A is a block diagram illustrating elements of a system 100 fortreating sleep disorders in accordance with embodiments of the presenttechnology. The system 100 can include a wearable device 101, a charger121, one or more implants or implantable devices (e.g., a firstimplantable device 120 a, a second implantable device 120 b . . . ann^(th) implantable device 120 n; referred to collectively as“implantable devices 120”) and a connected device or programmer 160. Ingeneral, the programmer 160 can transmit instructions for generating anelectrical signal (e.g., signal delivery or waveform parameters) to thewearable device 101, the wearable device 101 can transmit theinstructions and power to the implantable device(s) 120, and individualones of the implantable devices 120 can generate the electrical signalaccording to the transmitted instructions and apply the electricalsignal to a patient via electrodes carried by the implantable device(s)120. Many of the above-listed aspects of the system 100 are alsodescribed in greater detail below with reference to FIG. 3B.

The programmer 160 can include a patient-operated programmer and/or aclinician-operated programmer, and can be configured to control one ormore characteristics of the electrical signal delivered to the patient.In a representative embodiment, the programmer 160 can include a therapyadjustment module configured to select individual ones of the electrodescarried by the implantable device(s) 120 and adjust (e.g., increase ordecrease) an amplitude, frequency, pulse width, a burst duration,whether the electrode is active or inactive, and/or any other suitablesignal delivery parameter. Additionally, the programmer 160 cansynthesize information (e.g., diagnostic and/or feedback information)received from the wearable 101 and/or individual ones of the implantabledevices 120, and can adjust one or more of the signal deliveryparameters based at least partially on the synthesized information. Theprogrammer 160 can transmit the signal delivery parameters to theimplantable device(s) 120 directly and/or via the wearable device 101.For example, the programmer 160 can be connected to individual ones ofthe implantable devices 120 and/or the wearable device 101 via a wiredor wireless communication link, such as WiFi, Bluetooth (“BT”), cellularconnectivity, and/or any other suitable communication link. In these andother embodiments, the programmer 160 can be connected to a cloud 162and/or other computer service, e.g., to upload data received from thewearable device's 101 sensors and/or to download information to thewearable device 101 and/or the implantable device(s) 120. In these andother embodiments, the programmer 160 can include a display and/or auser interface. A user (e.g., the patient, the clinician, and/or othersuitable user) can interact with and/or otherwise control one or moreaspects of the programmer 160 via the user interface, e.g., to manuallyadjust one or more of the signal delivery parameters, to read datareceived from the wearable device 101 sensors, and/or carry out othertasks.

The wearable device 101 can include one or more sensors (e.g., a singlesensor, an array of sensors, and/or other suitable sensor arrangements)configured to collect data associated with a patient. The wearabledevice can further include a power source (e.g., a stored power deviceand/or battery), a power transmission component configured to transmitpower and/or signal delivery parameters to the implantable device(s)120, and one or more algorithms configured to control one or moreaspects of the operation of the wearable device 101. Individual ones ofthe sensors can collect data associated with the patient, such as apatient's sleep state and/or respiratory performance. The one or morealgorithms can be configured to adjust at least one of the signaldelivery parameters based at least partially on the data collected bythe sensors. In a representative embodiment, the wearable 101 caninclude an integrated sleep, respiratory diagnostics, and/or therapymodulation system configured to adjust or otherwise control one or moredelivery parameters of the electrical signal delivered to the patientbased on the collected sleep state and/or respiratory performance data,e.g., via one of more algorithms

In some embodiments, the wearable device 101 can further include a coveror housing, at least a portion of which may be removeable, e.g., toexpose an interior or interior portion of the wearable device 101. Inthese and other embodiments, the wearable device 101 cover can includefabric, or any other suitable material. Optionally, the wearable device100 can include a reduced and/or simplified user interface configured toallow a user to interact with and/or otherwise control one or more ofthe elements of the wearable device 101 (e.g., check a charging statusof the power source, adjust one or more of the signal deliveryparameters, etc.).

The charger 121 for the wearable device 101 can be configured to supplypower to the wearable device's 101 power source. The charger 121 caninclude a wireless (e.g., inductive) charger, a wired charger (e.g.,wall-plug, charging cable, etc.), and/or any other suitable charger orcharging device. Optionally, the charger 121 can include an integratedcontroller and/or a connected device, e.g., to control the charging ofthe wearable device 101 and/or to upload/download data to the wearabledevice 101 while the wearable device 101 is charging.

Individual ones of the one or more implantable devices 120 can includeRFID (e.g., a unique RFID tag that can be used to identify and/or locatethe associated implantable device 120 a-n), an electrode receiverantenna (e.g., an RF power antenna), a power rectifier/DC-DC converter,circuitry (e.g., one or more application-specific integrated circuits(ASICs), a state machine, etc.), a signal generator, and two or moreelectrodes that are each individually selectable to deliver anelectrical signal to a patient. The electrode receiver antenna canreceive power from the power transmission component of the wearabledevice. The power rectifier/DC-DC converter can be operably coupled tothe electrode receiver antenna, and can be configured to transmit thereceived power to the signal generator. Additionally, each of theimplantable devices 120 can receive, via the electrode receiver antenna,information regarding one or more of the delivery parameters of theelectrical signal to be generated by the signal generator and/ordelivered to the patient via at least one of the electrodes of theimplantable device(s) 120. The circuitry can include machine-readableinstructions associated with the operation of the implantable device(s)120. For example, the circuitry can include instructions that, whenexecuted, can cause the signal generator to generate the electricalsignal having the signal delivery parameter(s) received via theelectrode receiver antenna. In these and other embodiments, theelectrode receiver antenna can be used to transmit informationassociated with the implantable device 120 to the wearable device 101.For example, the implantable device 120 can transmit, to the wearabledevice 100 via the electrode receiver antenna, information associatedwith one or more of the signal delivery parameters of the electricalsignal being applied to the patient. In these and other embodiments,individual ones of the one or more implantable devices 120 can include ahermetic package or housing configured such that the implantabledevice(s) 120 can be implanted within a patient.

FIG. 3B is a partially schematic, isometric illustration of arepresentative implementation of the system 100 of FIG. 3A, shown in thecontext of the patient's anatomy, in a view similar to that describedabove with reference to FIG. 1. In a representative embodiment, thesystem 100 includes both implanted elements and external elements. Theimplanted elements can include the one or more implantable devices 120.Each implantable device 120 can include a signal delivery device 130positioned adjacent to the target neural and/or muscle structure. Thesignal delivery device 130 can be secured in place with suture threadsand/or other devices, e.g., anchors. The signal delivery device 130 isoperatively coupled to a signal generator 110. In some embodiments, allthe signal generation functions are performed by the implantable device120, and in other embodiments, some signal generation functions may beperformed by external elements. The signal generation functions andsignal delivery functions may be performed by a single implantabledevice 120, or multiple devices.

The wearable device 101 can carry a power source 109. For purposes ofillustration, the wearable device 101 is shown in FIG. 3B as includingan intraoral device 123, e.g., a mouthpiece, that in turn carries thepower source 109. As indicated above, the wearable device 101 can haveother suitable configurations (e.g., collar, chinstrap, pillow, mattressoverlay, among others) in other embodiments. The power source 109provides power to a signal generator 110, which generates and directssignals (e.g., therapy signals) to one or more electrodes 131 carried bya signal delivery device 130. The signal delivery device 130 can beimplanted at or proximate to the patient's hypoglossal nerve HGN using aminimally invasive technique, e.g., using a percutaneous injectionneedle. The power source 109 provides power to the signal generator 110via a wireless power transmission link 114, for example, a midfield RFtransmission link.

The signal generator 110 is typically controlled by the wearable device101, which in turn can be controlled by the programmer 160 and/or anyother suitable device, via a wireless programmer link 161. Accordingly,the patient P and/or a clinician can use the programmer 160 to directthe signal generator 110 (via the wearable device 101) to provideparticular signals to particular electrodes, at particular times and/orin accordance with particular sequences. The programmer link 161 can bea two-way link, so that the programmer 160 (in addition to providinginstructions to the wearable device 101 and/or the signal generator 110)can receive data regarding the therapy, the status of system components,and/or other suitable metrics. The data can be collected by one or moresensors 119 carried by the wearable device 101 (as shown schematicallyin FIG. 3B), and/or by the implantable device 120. In addition, theprogrammer 160 can communicate with the cloud 162 and/or other computerservices to upload data received from the patient P, and/or downloadinformation to the wearable device 101 and/or the implantable device(s)120. Downloaded data can include instructions and/or other dataregarding suitable treatments (e.g., from other similarly-situatedpatients), updates for software executed on the circuitry carried by thewearable device 101 and/or the implantable device(s) 120, and/or otheruseful information. In other embodiments, the implantable device(s) 120and/or the wearable device 101 include state machine components, whichare not updatable. Representative data received from the patient caninclude respiratory rate, sleep state, wake state, heart rate, audiosignals (corresponding to audible snoring, hypopnea events, and/or apneaevents), body temperature, head orientation/position, saturated bloodoxygen levels, air flow levels, thyroid movement, trachea movement,and/or tongue movement, photoplethysmography (PPG) data, among others.The data received from the patient can be generated by sensors 119carried by the wearable device 101 and/or the implantable device 120. Ina representative embodiment, the wearable device 101 performs executivefunctions, e.g., synthesizing information received from the programmer160 and/or the sensors 119 to initiate, adjust and/or halt the therapyprovided to the patient. The circuitry carried by the wearable devicecan accordingly include a controller programed with instructions toinitiate, change, and/or halt the therapy delivered the implantabledevice, based on information received from the sensors. The receiveddata can correspond to a measure of the patient's respiratoryperformance, sleep state, wake state, and/or other suitable metrics, forexample, metrics that are used to rate the patient on the Apnea-HypopneaIndex (AHI).

In any of the foregoing embodiments, the wearable device 101 transmitspower to the implantable devices 120 via the one or more powertransmission links 112, and receives power (e.g., on an intermittentbasis) from the charger 121. The charger 121 can accordingly include aconventional inductive coupling arrangement (e.g., Qi standard charging)and/or a conventional wired connection, as described previously and withreference to FIG. 3A.

In order to fit comfortably, the wearable device 101 (whether anintraoral device 123 or other type of wearable) can be custom-fit to thepatient, or can be made available in different sizes, and/or can bepartially configurable to fit individual patients. The intraoral device123 is particularly suitable when the associated signal delivery device130 is positioned at or proximate to target neural populations (e.g.,the HGN) within the oral cavity. Whether the wearable device has amouthpiece form factor or another suitable form factor, it can providepower to the implantable device 120, even if the implantable device isused to target neural populations other than, and/or in addition to, theHGN, e.g., branches of the vagus and/or ansa cervicalis nerves. In stillfurther embodiments, the power source 109 can be mounted to thepatient's skin via an adhesive, though it is expected that avoiding anadhesive will be more desirable/effective for the patient.

With reference to the specific embodiment shown in FIG. 3B, theintraoral device 123 can include both an upper mouthpiece portion 111,and a lower mouthpiece portion 112. The two mouthpiece portions 111, 112can be coupled together via a connector 113. The connector 113 canprovide a wired communication link between the two mouthpiece portions,and/or the connector 113 can mechanically position (and/or maintain theposition of, or stabilize) the lower mouthpiece portion 112 relative tothe upper mouthpiece portion 111. This approach can be used to, forexample, advance the patient's lower jaw or mandible M relative to thepatient's upper jaw, which is indicated by the bone structure BS in FIG.3B. For example, embodiments of the present technology avoid or at leastreduce jaw laxity (the patient's mouth hanging agape) using physicalelements of the wearable device 101, in addition to the electricalstimulation powered by the wearable device. For example, a wearabledevice that includes a collar and/or chin strap can mechanicallystabilize the patent's jaw in a target position.

The power source 109 can include one or more charge storage devices 116(e.g., one or more batteries) that receive power from the charger 121and store the power for transmission to the signal implantable device120. Accordingly, the power source 109 can include circuitry 115 (e.g.,first circuitry) that receives power from the charge storage device 116,conditions the power, and transmits the power to a power transmissionantenna 118. The power transmission antenna 118 in turn transmits thepower to the implantable device 120 via the wireless power transmissionlink 114 and an electrode receiver antenna 133 carried by the signaldelivery device 130.

The intraoral device 123 can further include a data transceiver antenna117 that receives data from the programmer 160, and/or transmits data tothe programmer 160. Data transmitted to the programmer 160 can includesensor data obtained from one or more sensor(s) 119. Accordingly, theintraoral device 123 can carry the functional elements/componentsrequired to direct power to the signal delivery device 130, and cancommunicate with the programmer 160 so as to provide effective therapyfor the patient. Further details of the signal delivery device 130 andthe signal generator 110 are described below with reference to FIGS.4-8B.

FIG. 4 is a partially schematic side view of a signal delivery device130 having elements configured in accordance with representativeembodiments of the present technology. Representative dimensions areindicated in FIG. 4 to provide a sense of scale, but the technology isnot limited by these dimensions unless expressly stated. The signaldelivery device 130 includes a lead body 134, which can be generallyflexible, and can carry one or more electrodes 131, which are generallyrigid in some embodiments, and may be flexible in others. Flexibleelectrodes can increase the flexibility of the lead body generally toaccommodate the tortuous anatomy/insertion path near the target nerve.For purposes of illustration, the lead body 134 is shown as carryingfour electrodes 131 in FIG. 4, but in other embodiments, the lead body134 can carry other suitable numbers of electrodes, for example, twoelectrodes 131. The electrodes 131 can be arranged in an array, forexample, a one-dimensional linear array. The electrodes 131 can includeconventional ring-shaped, or cylindrical electrodes, manufactured from asuitable, bio-compatible material, such as platinum/iridium, stainlesssteel, MP35N and/or or other suitable conductive implant materials. Theelectrodes 131 can each be connected to an individual conductor 140, forexample, a thin wire filament, that extends through the lead body 134.Each electrode 131 can have a length of approximately 1.5 mm as shown inFIG. 4, or another suitable length in other embodiments. To provide aclosed circuit, electrodes 131 are typically connected in (at least)pairs. A housing 135 and/or portions of the housing 135 can act as anelectrode, e.g., a ground or return electrode.

The lead body 134 is connected to, and carried by, the housing 135,which in turn carries the signal generator 110 and circuit elements forreceiving power. For example, the overall housing 135 can include anantenna housing or housing portion 135 a and a circuit housing orhousing portion 135 b. The antenna housing 135 a may be flexible, andcan carry a receiver antenna 133 (or other suitable power receptiondevice), which receives power from the wearable device 101 (FIGS. 3A and3B) via the wireless transmission link 114. The circuit housing 135 bcan have the form of a generally cylindrical metallic “can” formed fromtitanium and/or another suitable material. The signal generator 110 caninclude a charge pump and/or DC-DC converter 139 and/or circuitry 138(e.g., second circuitry) coupled to the receiver antenna 133. Thecircuitry 138 can include an ASIC, which can in turn includecorresponding machine-readable instructions. The instructions can beupdated wirelessly, using the electrode receiver antenna 133 for datatransfer in addition to power transfer. For example, data can betransferred using pulse-width modulation (PWM) and/or other suitabletechniques. Data can also be transferred in the opposite direction,e.g., using backscatter and/or other suitable techniques. For examplethe implantable device 120 can transmit a receipt to indicate that powerhas been received, and what magnitude the power is. This information canbe used to autoregulate (up or down) the output of the signal generator110, e.g., the transmitted signal and phase. Accordingly, the circuitry138 can include a processor and memory, including pre-programmed andupdatable instructions (e.g., in the form of an ASIC) for deliveringtherapy signals to the patient. For example, the system can include bootloader embedded firmware. Furthermore, the overall system can useRFID-type power transmission authorization to discriminate betweenmultiple implantable devices, which may be powered by a single wearabledevice 101. RFID and/or other techniques can be used to implementsecurity measures, e.g., to ensure that no foreign or unintendedstimulation occurs. Such techniques can be implemented with suitablehardware/software carried by the implantable device 120, in at leastsome embodiments.

The overall housing 135 can further include a base 136, which isgenerally rigid, and one or more anchors 137. The anchor(s) 137 securelyposition the implantable device 120 relative to the patient's tissue. Ina representative embodiment, the anchor 137 includes one or more tinesthat extend outwardly and into the patient's tissue when the implantabledevice 120 is injected or otherwise implanted in the patient. In otherembodiments, the implantable device 120 can include other suitableanchors, and/or anchoring may occur at the distal and/or mid-section ofthe signal delivery device 130. Other suitable anchors include but arenot limited to: (a) a bow spring that runs the longitudinal length ofthe electrode array and bows out to create fixation friction when theintroducer sheath is withdrawn; (b) a small wire on a spring-loadedhinge that runs the longitudinal length of the electrodes array and bowsout to create fixation friction when the introducer sheath is withdrawn;(c) a cam that, when rotated, expands in diameter to create frictionalfixation when the corresponding push rod is rotated by the implanter;and/or (d) a torsion spring that, when rotated, expands in diameter tocreate frictional fixation when the push rod is rotated by theimplanter.

To implant the implantable device 120, a practitioner uses a typical setof percutaneous implant tools, for example, an introducer, needle,cannula, and stylet, to position the implantable device 120 at thedesired target location. In a particular example, the implantable device120 is implanted percutaneously with a 3-4 Fr. needle. When theimplantable device 120 is advanced from the cannula, the anchor 137 candeploy outwardly and secure the implantable device 120 in position. Whenthe stylet is removed from the implantable device 120, for example, bywithdrawing the stylet axially from an aperture in the base 136 and/orother portions of the housing 135, the implantable device 120 is inposition to receive power and deliver therapy signals to the targetnerve.

In operation, the receiver antenna 133 receives power wirelessly fromthe power source 109 carried by the associated wearable device 101(FIGS. 3A and 3B, and described in further detail below with referenceto FIGS. 5A-6). In at least some embodiments, the power received at thereceiver antenna 133 is in a “midfield” range, for example, a radiofrequency in a range of from about 300 MHz to about 6 GHz, e.g., about600 MHz to about 2.45 GHz, or about 900 MHz to about 1.2 GHz. At thisfrequency, the useable range of the wireless power transmission link 114is about 10 cm, more than enough to cover the distance between theimplantable device 120 and the wearable device 101. At this range, thepower transmission process is not expected to cause tissue heating, andaccordingly provides an advantage over other power transmissiontechniques, for example, inductive transmission techniques. However, inembodiments for which the potential heating caused by inductive powertransmission is adequately controlled, inductive techniques can be usedin lieu of the midfield power transmission techniques described herein.

The AC power received at the receiver antenna 133 is rectified to DC,then transmitted to a DC-DC converter, charge pump, and/or transformer139, and converted to pulses in a range from about 10 Hz to about 300Hz. In other embodiments, the pulses can be delivered at a higherfrequency (e.g., 10 kHz or more), and/or in the form of bursts. Theamplitude of the signal can be from about 1 mV to about 5V (and inparticular embodiments, 1 V to 2 V) in a voltage-controlled system, orfrom about 1 mA to about 6 mA in a current-controlled system. Thecircuitry 138 controls these signal delivery parameters, and transmitsthe resulting electrical signal to the electrodes 131 via the wirefilaments or other conductors 140 within the lead body 134. Accordingly,the circuitry forms (at least part of) the signal generator 110 in thatit receives power that is wirelessly transmitted to the implantabledevice 120, and generates the signal that is ultimately delivered to thepatient. The electrical field(s) resulting from the currents transmittedby the electrodes 131 produces the desired effect (e.g., excitationand/or inhibition) at the target nerve. In at least some embodiments,the implantable device 120 need not include any on-board power storageelements (e.g., power capacitors and/or batteries), or any power storageelements having a storage capacity greater than 0.5 seconds, so as toreduce system volume. In other embodiments, the implantable device 120can include one or more small charge storage devices (e.g., capacitors)that are compatible with the overall compact shape of the implantabledevice 120, and have a total charge storage capacity of no more than 1second, 30 seconds, 1 minute, 2 minutes, or 5 minutes, depending on theembodiment.

In at least some embodiments, the electrical signal delivered to thepatient can be delivered via a bipole formed by two of the electrodes131. In other embodiments, the signal can be a monopolar signal, withthe housing 135 (e.g., the circuit housing 135 b) forming a ground orreturn electrode. In general, the waveform includes a biphasic, chargebalanced waveform, as will be discussed in greater detail below withreference to FIGS. 8A and 8B.

FIGS. 5A-6 illustrate wearable devices 101 configured to supply power tothe implantable device 120, in accordance with representativeembodiments of the present technology. Referring first to FIG. 5A, arepresentative wearable device 101 includes an intraoral device 123having an upper mouthpiece portion 111 and a lower mouthpiece portion112. The lower mouthpiece portion 112 includes one or more transmissionantennas 118 that direct power to the implantable device 120, describedabove with reference to FIG. 4. In a representative embodiment, thepatient has two implantable devices 120 implanted bilaterally, that is,at each of the patient's two hypoglossal nerves, one located on theright side of the patient's oral cavity, and the other located on theleft. Accordingly, the intraoral device 123 can include two powertransmission antennas 118, each positioned to direct power to one of theimplantable device 120. In an embodiment shown in FIG. 5A, the lowermouthpiece portion 112 includes two corresponding extensions 124,illustrated as a left extension 124 a, and a right extension 124 b. Eachextension 124 houses one of the transmission antennas 118, and ispositioned to locate the transmission antenna 118 close to thecorresponding implantable device 120, in a manner that remainscomfortable for the patient when the patient wears the intraoral device123.

The intraoral device 123 also includes one or more power supplies 116coupled to circuitry 115 that directs power to the transmission antennas118. The power supply 116 can include one or more batteries, capacitors,and/or other charge storage devices configured to store enough energy tosupply the signal delivery device(s) for a suitable therapy period. Asuitable therapy period typically includes at least four hours in someembodiments, and at least one night in other embodiments. The circuitry115 receives current from the power supply 116 and converts the currentto a suitable midfield radio frequency. The current is directed to thetransmission antenna(s) 118. In an embodiment shown in FIG. 5A, thecircuitry 115 and power supply 116 are carried by the lower mouthpieceportion 112, and are positioned along the outer surfaces of the lowermouthpiece portion 112, so as to face toward the patient's lower lip.With this arrangement, the electrical elements are not expected tointerfere with the anterior motion of the patient's tongue. In anotherembodiment, for example, as shown in FIG. 5B, the circuitry 115 and thepower supply 116 can be carried by the upper mouthpiece portion 111. Inthis embodiment, the circuitry 115 and power supply 116 are positionedalong the inner surfaces of the upper mouthpiece portion 111 so as toface toward the interior of the patient's oral cavity rather than towardthe patient's lips. Because the electrical elements are on the uppermouthpiece portion 111, they are not expected to interfere with theanterior motion of the patient's tongue, even though they face towardthe interior of the patient's oral cavity. The circuitry 115 directselectrical current to the antenna(s) via one or more wires (not shown inFIG. 5A) that pass through a corresponding connector 113 (shown in FIG.3B) coupled between the upper mouthpiece portion 111 and the lowermouthpiece portion 112.

FIG. 5C illustrates a further representative embodiment in which thewearable device 101 includes circuitry 115 carried by the uppermouthpiece portion 111, and a power supply 116 carried by the lowermouthpiece portion 112. In this case, a communication link carried bythe connector 113 (FIG. 3B) transmits current from the power supply 116to the circuitry 115, and then transmits current from the circuitry 115to the transmission antenna(s) 118 (not visible in FIG. 5C).

FIG. 6 is a partially schematic, isometric illustration of a wearabledevice 601 configured in accordance with still further embodiments ofthe present technology. The upper mouthpiece portion 111 includes a roofportion 622 extending transversely from one side of the upper mouthpieceportion 111 to the other, so as to be positioned upwardly against theroof of the patient's mouth. Several of the elements of the wearabledevice 101 can accordingly be carried by the roof portion 622. Suchelements can include the circuitry 115, the power supply 116, the datatransceiver antenna 117 (described above with reference to FIG. 3B), acharging coil 621 (for recharging the power supply 116 via the charger121, shown in FIGS. 3A and 3B), and one or more sensors 119 (alsodiscussed above with reference to FIGS. 3A and 3B). Accordingly, theroof portion 622 can provide additional volume in which to carry theforegoing elements of the wearable device 101. Sensors 119, for example,can include but are not limited to, temperature sensors such asthermistors and/or thermocouples, sound sensors, vibration sensors,pressure sensors, force sensors, strain gauges, magnetometers,accelerometers, gyroscopes, impedance sensors, EMG sensors, gas sensorsand/or chemical sensors, oxygen saturation sensors, photoplethysmographysensors, flow sensors (oral- or nasal-manometry), and/or other sensorsthat can sense conditions or characteristics (e.g., sleep state, wakestate) of the patient. In some representative embodiments, the patient'srespiration parameters can be used to trigger stimulation based on thepatient's breathing cycle as well as information that may indicate anapnea event is occurring or is likely to occur. In a particularembodiment, the overall system includes a pulse oximeter, aphotoplethysmography sensor, and at least one patient orientation sensorto provide suitable patient feedback on which to base system actions.

Any of the foregoing components described with reference to FIGS. 5A-6can be positioned along the outer surfaces of the mouthpiece portion(s),or in other embodiments, these components can face inwardly, rather thanoutwardly, from the mouthpiece portions. As indicated above, anadvantage of the components being on the outer surface of the mouthpieceis that the components would not impinge on the space occupied by thetongue as it protrudes forward during stimulation. In at least someembodiments, the battery can be positioned so that it can be readilyremoved and replaced.

FIG. 7 is a schematic illustration of an arrangement for controlling theelectrical signals applied to the patient, in accordance withrepresentative embodiments of the present technology. In general, thecontrol circuitry 115 provides current to one or more power transmissionantennas 118, which in turn direct the power to corresponding electrodereceiver antennas 133, via corresponding wireless power transmissionlinks 114.

For purposes of illustration, FIG. 7 illustrates two controlarrangements on a single device: one for the left side of the patient'soral cavity and one for the right. This is one possible organization,and in other embodiments, the same arrangement is used for both left andright sides. As shown in FIG. 7, a first receiver antenna 133 a canprovide signals to each of four corresponding electrodes 131. Two secondreceiver antennas 133 b can each provide power to two electrodes 131.The implemented arrangement can be selected based on the utilityassociated with controlling individual electrodes via correspondingreceiver antennas. For example, the first receiver antenna 133 a candeliver the same signal, simultaneously, to multiple electrodes 131(and/or pairs of electrodes 131) connected to it. On the other hand, thesecond receiver antennas 133 b can each deliver signals independently tothe corresponding electrodes to which they are coupled. This can allowthe second receiver antennas 133 b to sequence the signals applied tothe corresponding electrodes 131. In some embodiments, this arrangementcan advantageously allow the practitioner to direct one signal to oneportion of the hypoglossal nerve at one point in time, and the same oranother signal to another portion of the hypoglossal nerve, or anothernerve, at another point in time. It is expected that the ability tocontrol both spatial and temporal aspects of the signals delivered tothe target nerve, or nerves, can improve the efficacy with which thedevice reduces the patient's obstructive sleep apnea (OSA). For example,the signals may be delivered to different portions of the hypoglossalnerve, and/or to other nerves, including the ansa cervicalis (e.g., topromote caudal movement of the pharynx), and/or the vagal nerve, as itsbranches activate many muscles of the upper airway including the motormuscles of the larynx and the palatoglossus.

More generally, the multiple injectable electrodes 131 can be wirelesslyactivated by the remotely positioned wearable device, in a phased manner(e.g., with millisecond-range timing offsets) to sequence contractionsof the corresponding muscles and thereby address the patient's sleepingdisorder(s). In addition, the system has the flexibility to change thetarget neuron(s) to which the signal is directed, in combination withthe certainty and robustness provided by an implanted signal deliverydevice.

In at least some embodiments, the control circuitry 115 controls both ofthe power transmission antennas 118, and therefore provides overallcontrol of the signals delivered to the patient. In other embodiments,the authority to control one or more antenna(s) 118 and/or correspondingelectrodes 131 can be distributed. For example, one element of thecontrol circuitry can control one power transmission antenna 118 andanother can control the other power transmission antenna 118. Thecontrol authority can be further distributed among different receiverantenna(s) 133, as shown in FIG. 7. In any of these embodiments, whencontrol is distributed below the high level control circuitry 115, thesystem includes provisions that allow for communication betweenindividual controller elements so as to keep all the control elementssynchronized.

4. Representative Waveforms

The signal generators and delivery devices described above can generateand deliver any of a variety of suitable electrical stimulationwaveforms a to modulate the actions of the patient's neurons and/ormuscles. Representative examples are illustrated in FIGS. 8A and 8B andinclude a series of a biphasic stimulation pulses that form stimulationwave cycles having a period as identified in FIGS. 8A and 8B. Thewaveform parameters can include active cycles and rest cycles. Eachperiod P includes one or more pulses. The waveform shown in FIG. 8Acomprises an anodic pulse followed by an interphasic delay, a cathodicpulse and then an interpulse delay. Accordingly, the overall period P orcycle includes the following parameters: anodic pulse width (PW1),anodic amplitude (e.g., voltage or current amplitude VA), interphasicdelay/dead time, cathodic pulse width (PW2), cathodic amplitude (e.g.,voltage or current amplitude VC), interpulse delay/idle time, andpeak-to-peak amplitude (PP). The parameters may also include theidentity of the electrode(s) to which the signal is directed. The anodicpulse width (PW1) in some representative embodiments is between 30 μsand 300 μs. The anodic amplitude (VA) and cathodic amplitude (VC) insome representative embodiments ranges from 1 mV to 5 V, or 1 mA to 6mA. The interphasic delay in some representative embodiments can be from10 μs to 100 μs. The cathodic pulse width (PW1) is some representativeembodiments is between 30 μs and 300 μs. In representative embodiments,the anodic and cathodic phases are charge balanced, though the phasesneed not be symmetrically shaped. The interpulse delay in somerepresentative embodiments can be from 10 μs to 100 μs. The peak-to-peakamplitude in some representative embodiments can be from about 2 mA to12 mA. Representative frequencies range from about 10 Hz to about 300 Hzin some embodiments, and up to 100 kHz (e.g., 10 kHz) in others. Thepulses can be delivered continuously or in bursts.

FIG. 8B illustrates a representative waveform comprising an activeportion and a rest portion. The active portion includes one or moreperiods having the characteristics described above with reference toFIG. 8A. The rest portion has no stimulation pulses. According to somerepresentative embodiments, the ratio of active portion to rest portioncan be between 1:1 and 1:9. As a representative example, if the ratio is1:9, and there are 300 active periods, there can be 2700 rest portions.

In a representative example, the stimulation voltage may be presentedindependently to each contact or electrode. For the positive pulse, thepositive contact can be pulled to the drive voltage and the negativecontact is pulled to ground. For the negative pulse, the negativecontact can be pulled to the drive voltage and the positive contact ispulled to ground. For dead time and idle time, both contacts are drivento ground. For the rest time, both contacts are at a high impedance. Toprevent DC current in the contacts, each half-bridge can be coupled tothe contact through a capacitor, for example, a 100 μF capacitor. Inaddition, a resistor can be placed in series with each capacitor tolimit the current in the case of a shorted contact. The pulses of thetherapeutic waveform cycle may or may not be symmetric, but, aregenerally shaped to provide a net-zero charge across the contacts, e.g.,to provide charge balancing.

From the foregoing, it will be appreciated that specific embodiments ofthe disclosed technology have been described herein for purposes ofillustration, but that various modifications may be made withoutdeviating from the technology. For example, the power source andassociated wearable can have configurations other than an intraoralmouthpiece, that also deliver power wirelessly to one or more implantedelectrodes. Representative configurations include external, skin-mounteddevices, and devices that are worn around the patient's neck, which maybe suitable for targeting the ansa cervicalis, vagal nerve, and/or othernerves other than the HGN. Other representative targets for thestimulation include palatoglossal stimulation, cranial nervestimulation, direct palatoglossus muscle stimulation, hyolaryngealstimulation, and/or glossopharyngeal nerve stimulation. The anchor usedto secure the signal delivery device in place can have configurationsother than deployable tines, including s-curve elements, helixes, and/orporous structures that promote tissue in-growth. The signal deliverydevice was described above as including multiple housings that form anoverall housing. In other embodiments, the multiple housing can beportions of a unitary overall housing. The functions performed by theoverall system can be divided among the system elements (e.g., theprogrammer, wearable device, and implantable device) in manners otherthan those expressly shown and described herein.

Certain aspects of the technology described in the context of particularembodiments may be combined or eliminated in other embodiments. Forexample, signal delivery devices having any of a variety of suitableconfigurations can be used with any one signal generator, and signalgenerators having any of a variety of suitable configurations can beused with any one signal delivery device. Further, while advantagesassociated with certain embodiments of the disclosed technology havebeen described in the context of those embodiments, other embodimentsmay also exhibit such advantages, and not all embodiments neednecessarily exhibit such advantages to fall within the scope of thetechnology. Accordingly, the disclosure and associated technology canencompass other embodiments not expressly shown or described herein.

As used herein, the phrase “and/or,” as in “A” and/or “B” refers to Aalone, B alone and both A and B. To the extent any materialsincorporated herein by reference conflict with the present disclosure,the present disclosure controls. As used herein, the terms “about,”“approximately,” and similar terms of approximation refer to valueswithin 10% of the stated value.

The following examples provide additional representative features of thepresent technology.

Examples

1. A patient treatment system, comprising:

-   -   a wearable device carrying:        -   a power storage device;        -   a power transmission antenna coupled to the power storage            device and configured to emit an RF signal in a frequency            range of 300 MHz to 6 GHz; and        -   first control circuitry coupled between the power storage            device and the power transmission antenna; and    -   an implantable device having:        -   an electrode;        -   a housing carrying the electrode;        -   an anchor carried by the housing and positioned to secure            the implantable device to tissue in a patient's oral cavity;        -   an electrode receiver antenna configured to receive an RF            signal in a frequency range of 300 MHz to 6 GHz;        -   a signal generator coupled to the electrode receiver antenna            and the electrode to direct a signal to the electrode at a            frequency in a range of 10 Hz to 300 Hz; and        -   second circuitry coupled between the signal generator and            the electrode to control the delivery of the signal to the            electrode.

2. The system of example 1, wherein the implantable device isneedle-deliverable device, and wherein the electrodes are positioned tobe implanted proximate to a patient's hypoglossal nerve and/or ansacervicalis, and wherein the system further comprises:

-   -   at least one sensor carried by the wearable device or the        implantable device, the at least one sensor being configured to        detect a characteristic of the patient's respiratory        performance; and    -   a controller carried by the wearable device and programmed with        instructions that, when executed, initiate, change, and/or halt        the delivery of the signal to the electrode, based at least in        part on information received from the at least one sensor.

3. The system of example 2 wherein the at least one sensor includes apulse oximeter, a photoplethysmography sensor, and a patient orientationsensor.

4. The system of any of examples 1-3 wherein the implantable device doesnot include a charge storage element.

5. The system of any of examples 1-4 wherein the electrode is a firstelectrode, and wherein the implantable device includes a secondelectrode, and wherein at least one of the first circuitry or the secondcircuitry include instructions that, when executed, direct signals tothe first and second electrodes that are sequenced, with the firstelectrode delivering a first signal to the patient at a first point intime, and the second electrode delivering a second signal to the patientat a second point in time.

6. The system of any of examples 1-4 wherein the wearable deviceincludes an intraoral device configured to be positioned within thepatient's oral cavity.

7. The system of example 6 wherein at least a first portion of theintraoral device is shaped to conform to at least a second portion ofthe patient's oral cavity.

8. The system of example 6 wherein the intraoral device includes anupper mouthpiece portion, a lower mouthpiece portion and a connectorcoupling the upper and lower mouthpiece portions.

9. The system of example 8 wherein the lower mouthpiece portion ismovable relative to the upper mouthpiece portion to advance thepatient's mandible.

10. The system of example 8 wherein the lower mouthpiece portion carriesthe power transmission antenna, the charge storage device, and the firstcircuitry.

11. The system of example 8 wherein the lower mouthpiece portion carriesthe power transmission antenna and the upper mouthpiece portion carriesthe charge storage device and the first circuitry.

12. The system of example 11 wherein the upper mouthpiece portionincludes a roof portion that carries the charge storage device or thefirst circuitry.

13. The system of example 8 wherein the lower mouthpiece portion carriesthe power storage device, the upper mouthpiece portion carries the firstcircuitry, and the connector includes a communication link to transmitpower from the power supply to the circuitry.

14. The system of example 8 wherein at least at least a part of thelower mouthpiece portion is shaped to conform to a lower region of thepatient's oral cavity.

15. The system of example 8 wherein at least a part of the uppermouthpiece portion is shaped to conform to an upper region of thepatient's oral cavity.

16. The system of any of examples 1-15 wherein (i) the implantabledevice is a first implantable device positioned on a first side of thepatient's oral cavity and (ii) the electrode is a first electrode, thesystem further comprising a second implantable device positioned on asecond side of the patient oral cavity opposite the first implantabledevice, the second implantable device including a second electrode.

17. The system of any of examples 1-5 wherein the wearable deviceincludes at least one of a neck collar, a chinstrap, a pillow, and/or amattress overlay.

18. The system of any of examples 1-17 wherein at least one of the firstcircuitry or the second circuitry include instructions that, whenexecuted, cause the electrode to deliver a signal to the patient,wherein the signal includes at least one of:

-   -   a pulse width between 30 us and 300 us;    -   an anodic amplitude between 1 mA and 6 mA or between 1 mV and 5        V; and    -   a cathodic amplitude between 1 mA and 6 mA or between 1 mV and 5        V.

19. The system of example 1 wherein the wearable device further includesat least one sensor positioned to detect at least one physiologicalparameter of the patient, the at least one physiological parameterincluding at least one of a respiratory rate, a heart rate, an audiosignal, a body temperature, a head position, a saturated blood oxygenlevel, an air flow level, movement of the patient's larynx, and/ormovement of the patient's tongue.

20. An sleep apnea treatment system, comprising:

-   -   an intraoral device configured to fit within a patient's oral        cavity, the intraoral device including—        -   a lower mouthpiece portion carrying a power transmission            antenna configured to emit an RF signal at a first            frequency, and        -   an upper mouthpiece portion opposite the lower mouthpiece            portion, the upper mouthpiece portion carrying—            -   a power storage device operably coupled to the power                transmission antenna, and            -   first control circuitry operably coupled to the power                storage device and the power transmission antenna; and        -   a connector coupling the lower portion and the upper            portion; and    -   an implantable device having:        -   an electrode,        -   an electrode receiver antenna configured to receive the RF            signal emitted by the power transmission antenna,        -   a signal generator coupled to the electrode receiver antenna            and the electrode and operable to direct a stimulus signal            to the electrode at a second frequency, and        -   second circuitry coupled between the signal generator and            the electrode to control the delivery of the stimulus signal            to the electrode.

21. The sleep apnea treatment system of example 20 wherein theimplantable device does not include a charge storage element.

22. The sleep apnea treatment system of any of examples 20-21 whereinthe electrode is a first electrode, and wherein the implantable deviceincludes a second electrode, and wherein at least one of the firstcircuitry or the second circuitry include instructions that, whenexecuted, direct signals to the first and second electrodes that aresequenced, with the first electrode delivering a signal to the patientat a first point in time, and the second electrode delivering a signalto the patient at a second point in time.

23. A method of directing an electrical signal to a person, comprising:

-   -   programming a wearable device to transmit, via a power        transmission antenna of the wearable device positioned to be in        wireless communication with a receiver antenna of an implantable        device, a first electrical signal, at least a portion of the        first electrical signal having a first frequency in a first        frequency range from about 300 MHz to about 6 GHz; and    -   programming a pulse generator of the implantable device to—        -   receive, via the electrode receiver antenna, the first            electrical signal; and        -   deliver, via at least one electrode of the implantable            device positioned to be in electrical communication with a            target nerve of the person, a second electrical signal, at            least a portion of the second electrical signal having a            second frequency in a second frequency range of up to 100            kHz.

24. The method of example 23 wherein the first frequency range is fromabout 900 MHz to about 1.2 GHz.

25. The method of any of examples 23-24 wherein the second frequencyrange is from about 10 Hz to about 300 Hz.

26. The method of any of examples 23-25 wherein the portion of thesecond electrical signal further includes an anodic amplitude in ananodic amplitude range from 1 mV to 5V or from 1 mA to 6 mA

27. The method of any of examples 23-26 wherein the portion of thesecond electrical further includes an interphase delay in an interphasedelay range from 10 μs to 100 μs.

28. The method of any of examples 23-27 wherein the portion of thesecond electrical signal further includes an interpulse delay in aninterpulse delay range from 10 μs to 100 μs.

29. The method any of examples 23-28 wherein the portion of the secondelectrical signal further includes a peak-to-peak amplitude in apeak-to-peak amplitude range from 2 mA to 12 mA.

30. The method of any of examples 23-29 wherein the person has sleepapnea.

31. The method of example any of examples 23-30 wherein programming thepulse generator includes programming the pulse generator to deliver thesecond electrical signal over a therapy period.

32. The method of example 31 wherein the therapy period lasts at leastfour hours.

33. The method of example 31 wherein the therapy period includes atleast one active portion and at least one rest portion.

34. A method of treating a patient, comprising:

-   -   percutaneously implanting an implantable device proximate a        medial branch of the patient's hypoglossal nerve such that an        electrode carried by the implantable device is positioned to be        in electrical communication with the medial branch of the        patient's hypoglossal nerve;    -   transmitting a first signal from a power transmission antenna of        a wearable device to a receiver antenna of the implantable        device;    -   converting, via a signal generator of the implantable device,        the first signal into a second signal; and    -   applying, via the electrode, the second signal to the medial        branch of the patient's hypoglossal nerve.

35. The method of example 34 wherein transmitting the first signalincludes transmitting the first signal in a frequency range from about300 MHz to about 6 GHz.

36. The method of any of examples 34-35 wherein transmitting the secondsignal includes transmitting the second signal in a frequency range ofup to 100 kHz.

37. The method of any of examples 34-36 wherein transmitting the secondsignal includes transmitting the second signal in a frequency range fromabout 10 Hz to about 300 Hz.

38. The method of any of examples 34-37 wherein the electrode is a firstelectrode, and wherein applying the second signal includes:

-   -   applying, via the first electrode, a first portion of the second        signal at a first point in time; and    -   applying, via the second electrode, a second portion of the        second signal at a second point in time;

39. The method of any of examples 34-38 wherein the implantable deviceis a first implantable device and the electrode is a first electrode,the method further comprising:

-   -   percutaneously implanting a second implantable device such that        a second electrode carried by the second implantable device is        positioned to be in electrical communication with at least a        portion of the patient's hypoglossal nerve, ansa cervicalis        nerve, vagal nerve, glossopharyngeal nerve, palatoglossus        muscle, or hyolaryngeal complex.

40. The method of example 39 wherein:

-   -   implanting the first implantable device include implanting the        first implantable device on a first side of the patient's oral        cavity; and        implanting the second implantable device includes implanting the        second implantable device on a second side of the patient's oral        cavity.

I/We claim:
 1. A patient treatment system, comprising: a wearable devicecarrying: a power storage device; a power transmission antenna coupledto the power storage device and configured to emit an RF signal in afrequency range of 300 MHz to 6 GHz; and first control circuitry coupledbetween the power storage device and the power transmission antenna; andan implantable device having: an electrode; a housing carrying theelectrode; an anchor carried by the housing and positioned to secure theimplantable device to tissue in a patient's oral cavity; an electrodereceiver antenna configured to receive an RF signal in a frequency rangeof 300 MHz to 6 GHz; a signal generator coupled to the electrodereceiver antenna and the electrode to direct a signal to the electrodeat a frequency in a range of 10 Hz to 300 Hz; and second circuitrycoupled between the signal generator and the electrode to control thedelivery of the signal to the electrode.
 2. The system of claim 1,wherein the implantable device is needle-deliverable device, and whereinthe electrodes are positioned to be implanted proximate to a patient'shypoglossal nerve and/or ansa cervicalis, and wherein the system furthercomprises: at least one sensor carried by the wearable device or theimplantable device, the at least one sensor being configured to detect acharacteristic of the patient's respiratory performance; and acontroller carried by the wearable device and programmed withinstructions that, when executed, initiate, change, and/or halt thedelivery of the signal to the electrode, based at least in part oninformation received from the at least one sensor.
 3. The system ofclaim 2 wherein the at least one sensor includes a pulse oximeter, aphotoplethysmography sensor, and a patient orientation sensor.
 4. Thesystem of claim 1 wherein the implantable device does not include acharge storage element.
 5. The system of claim 1 wherein the electrodeis a first electrode, and wherein the implantable device includes asecond electrode, and wherein at least one of the first circuitry or thesecond circuitry include instructions that, when executed, directsignals to the first and second electrodes that are sequenced, with thefirst electrode delivering a first signal to the patient at a firstpoint in time, and the second electrode delivering a second signal tothe patient at a second point in time.
 6. The system of claim 1 whereinthe wearable device includes an intraoral device configured to bepositioned within the patient's oral cavity.
 7. The system of claim 6wherein at least a first portion of the intraoral device is shaped toconform to at least a second portion of the patient's oral cavity. 8.The system of claim 6 wherein the intraoral device includes an uppermouthpiece portion, a lower mouthpiece portion and a connector couplingthe upper and lower mouthpiece portions.
 9. The system of claim 8wherein the lower mouthpiece portion is movable relative to the uppermouthpiece portion to advance the patient's mandible.
 10. The system ofclaim 8 wherein the lower mouthpiece portion carries the powertransmission antenna, the charge storage device, and the firstcircuitry.
 11. The system of claim 8 wherein the lower mouthpieceportion carries the power transmission antenna and the upper mouthpieceportion carries the charge storage device and the first circuitry. 12.The system of claim 11 wherein the upper mouthpiece portion includes aroof portion that carries the charge storage device or the firstcircuitry.
 13. The system of claim 8 wherein the lower mouthpieceportion carries the power storage device, the upper mouthpiece portioncarries the first circuitry, and the connector includes a communicationlink to transmit power from the power supply to the circuitry.
 14. Thesystem of claim 8 wherein at least at least a part of the lowermouthpiece portion is shaped to conform to a lower region of thepatient's oral cavity.
 15. The system of claim 8 wherein at least a partof the upper mouthpiece portion is shaped to conform to an upper regionof the patient's oral cavity.
 16. The system of claim 1 wherein (i) theimplantable device is a first implantable device positioned on a firstside of the patient's oral cavity and (ii) the electrode is a firstelectrode, the system further comprising a second implantable devicepositioned on a second side of the patient oral cavity opposite thefirst implantable device, the second implantable device including asecond electrode.
 17. The system of claim 1 wherein the wearable deviceincludes at least one of a neck collar, a chinstrap, a pillow, and/or amattress overlay.
 18. The system of claim 1 wherein at least one of thefirst circuitry or the second circuitry include instructions that, whenexecuted, cause the electrode to deliver a signal to the patient,wherein the signal includes at least one of: a pulse width between 30 usand 300 us; an anodic amplitude between 1 mA and 6 mA or between 1 mVand 5 V; and a cathodic amplitude between 1 mA and 6 mA or between 1 mVand 5 V.
 19. The system of claim 1 wherein the wearable device furtherincludes at least one sensor positioned to detect at least onephysiological parameter of the patient, the at least one physiologicalparameter including at least one of a respiratory rate, a heart rate, anaudio signal, a body temperature, a head position, a saturated bloodoxygen level, an air flow level, movement of the patient's larynx,and/or movement of the patient's tongue.
 20. An sleep apnea treatmentsystem, comprising: an intraoral device configured to fit within apatient's oral cavity, the intraoral device including— a lowermouthpiece portion carrying a power transmission antenna configured toemit an RF signal at a first frequency, and an upper mouthpiece portionopposite the lower mouthpiece portion, the upper mouthpiece portioncarrying— a power storage device operably coupled to the powertransmission antenna, and first control circuitry operably coupled tothe power storage device and the power transmission antenna; and aconnector coupling the lower portion and the upper portion; and animplantable device having: an electrode, an electrode receiver antennaconfigured to receive the RF signal emitted by the power transmissionantenna, a signal generator coupled to the electrode receiver antennaand the electrode and operable to direct a stimulus signal to theelectrode at a second frequency, and second circuitry coupled betweenthe signal generator and the electrode to control the delivery of thestimulus signal to the electrode.
 21. The sleep apnea treatment systemof claim 20 wherein the implantable device does not include a chargestorage element.
 22. The sleep apnea treatment system of claim 20wherein the electrode is a first electrode, and wherein the implantabledevice includes a second electrode, and wherein at least one of thefirst circuitry or the second circuitry include instructions that, whenexecuted, direct signals to the first and second electrodes that aresequenced, with the first electrode delivering a signal to the patientat a first point in time, and the second electrode delivering a signalto the patient at a second point in time.
 23. A method of directing anelectrical signal to a person, comprising: programming a wearable deviceto transmit, via a power transmission antenna of the wearable devicepositioned to be in wireless communication with a receiver antenna of animplantable device, a first electrical signal, at least a portion of thefirst electrical signal having a first frequency in a first frequencyrange from about 300 MHz to about 6 GHz; and programming a pulsegenerator of the implantable device to— receive, via the electrodereceiver antenna, the first electrical signal; and deliver, via at leastone electrode of the implantable device positioned to be in electricalcommunication with a target nerve of the person, a second electricalsignal, at least a portion of the second electrical signal having asecond frequency in a second frequency range of up to 100 kHz.
 24. Themethod of claim 23 wherein the first frequency range is from about 900MHz to about 1.2 GHz.
 25. The method of claim 23 wherein the secondfrequency range is from about 10 Hz to about 300 Hz.
 26. The method ofclaim 23 wherein the portion of the second electrical signal furtherincludes an anodic amplitude in an anodic amplitude range from 1 mV to5V or from 1 mA to 6 mA
 27. The method of claim 23 wherein the portionof the second electrical further includes an interphase delay in aninterphase delay range from 10 μs to 100 μs.
 28. The method of claim 23wherein the portion of the second electrical signal further includes aninterpulse delay in an interpulse delay range from 10 μs to 100 μs. 29.The method of claim 23 wherein the portion of the second electricalsignal further includes a peak-to-peak amplitude in a peak-to-peakamplitude range from 2 mA to 12 mA.
 30. The method of claim 23 whereinthe person has sleep apnea.
 31. The method of claim 23 whereinprogramming the pulse generator includes programming the pulse generatorto deliver the second electrical signal over a therapy period.
 32. Themethod of claim 31 wherein the therapy period lasts at least four hours.33. The method of claim 31 wherein the therapy period includes at leastone active portion and at least one rest portion.
 34. A method oftreating a patient, comprising: percutaneously implanting an implantabledevice proximate a medial branch of the patient's hypoglossal nerve suchthat an electrode carried by the implantable device is positioned to bein electrical communication with the medial branch of the patient'shypoglossal nerve; transmitting a first signal from a power transmissionantenna of a wearable device to a receiver antenna of the implantabledevice; converting, via a signal generator of the implantable device,the first signal into a second signal; and applying, via the electrode,the second signal to the medial branch of the patient's hypoglossalnerve.
 35. The method of claim 34 wherein transmitting the first signalincludes transmitting the first signal in a frequency range from about300 MHz to about 6 GHz.
 36. The method of claim 34 wherein transmittingthe second signal includes transmitting the second signal in a frequencyrange of up to 100 kHz.
 37. The method of claim 34 wherein transmittingthe second signal includes transmitting the second signal in a frequencyrange from about 10 Hz to about 300 Hz.
 38. The method of claim 34wherein the electrode is a first electrode, and wherein applying thesecond signal includes: applying, via the first electrode, a firstportion of the second signal at a first point in time; and applying, viathe second electrode, a second portion of the second signal at a secondpoint in time;
 39. The method of claim 34 wherein the implantable deviceis a first implantable device and the electrode is a first electrode,the method further comprising: percutaneously implanting a secondimplantable device such that a second electrode carried by the secondimplantable device is positioned to be in electrical communication withat least a portion of the patient's hypoglossal nerve, ansa cervicalisnerve, vagal nerve, glossopharyngeal nerve, palatoglossus muscle, orhyolaryngeal complex.
 40. The method of claim 39 wherein: implanting thefirst implantable device include implanting the first implantable deviceon a first side of the patient's oral cavity; and implanting the secondimplantable device includes implanting the second implantable device ona second side of the patient's oral cavity.